Ethics and federal laws about human subject protections have evolved to protect research participants in general and vulnerable groups in particular. Under federal law, vulnerable groups include pregnant women;fetuses, neonates, and children;and prisoners. According to ethicists, vulnerable groups also include individuals who suffer from impairment due to mental illness, stigmatized medical illness, and other debilitating disorders. Given these definitions, prisoners with mental illnesses are multiply vulnerable. With the number of prisoners with serious psychiatric disorders exceeding the number of patients in psychiatric hospitals, jails and prisons have become "America's new mental hospitals" (Torrey, 1995) and for many individuals with mental illness, inpatient psychiatric care is now provided in jails and prisons (Lamb &Weinberger, 2005). Research with prisoners, especially those with the added vulnerability of mental illness, poses ethical challenges and responsibilities, yet there have been no empirical studies of the interpretation and application of ethical principles and regulatory safeguards by researchers and IRBs involved in mental health research with prisoners. This application focuses on 1) how researchers and IRB members interpret and apply ethical principles of autonomy, justice, and beneficence in mental health research with prisoners;2) how researchers and IRB members interpret and apply regulatory safeguards for mental health research with prisoners;3) ways in which policies and structural environments of correctional systems (including prisons and jails) create ethical challenges that must be addressed by mental health researchers and IRBs;and 4) ways in which ethical safeguards and oversight affect mental health research with prisoners. This project will use sequential qualitative and quantitative phases to examine ethical challenges, responsibilities, and solutions regarding the conduct and oversight of mental health research with prisoners. Phase 1 involves key informant interviews with individuals who have conducted mental health research with prisoners;IRB Chairs and members;IRB prisoner representatives;prison administrators;and research ethicists. Using these data, Phase 2 focuses on construction of a quantitative survey about ethical challenges and solutions. In Phase 3, this survey is administered to a national sample of mental health researchers, IRB chairs and members, and IRB prisoner representatives. In Phase 4, findings from prior phases are taken to prison administrators, security officials, and medical officials, and prison advocacy group members, to gather their perspectives on the meaning and implications of these findings. Phase 5 focuses on initiating a data-driven dialogue through dissemination of research findings to important stakeholder groups, including researchers;IRB chairs, members, and prison representatives;and prison administrators, medical staff, and security personnel to result in enhanced application of ethics and regulatory safeguards to mental health research with prisoners, with the goal of reducing barriers to epidemiologic and intervention research focused on mental illness among prisoners. PUBLIC HEALTH RELEVANCE: Prisons have become "America's new mental hospitals", housing, but rarely treating, as many individuals with mental disorders as all psychiatric hospitals in the US combined. By providing an empirical basis with which to strengthen ethical safeguards for mental health research in correctional systems, this project will contribute to the enhancement of research-based treatment for prisoners with mental illness. Of great relevance to public health, our work will provide ethical guidance to researchers, IRBs, and prison officials;enhance the quality, conduct, and range of mental health research in prison populations;and, ultimately, enhance the health and safety of prisoners and the communities to which they return upon release.